Erythropoietin to Enhance Recovery of Erectile Function in Men Following Radical Prostatectomy

Completed · Phase 2 · Has a placebo group

Conditions studied: Prostate Cancer, Erectile Dysfunction

In brief

This research study aims to explore the effectiveness of human erythropoietin versus placebo in promoting the recovery of erectile function in patients undergoing bilateral nerve-sparing radical retropubic prostatectomy for clinically localized prostate cancer. Pre-clinical studies have shown erythropoietin potently promoted recovery of erectile function in rats and humans have similar receptors on penile tissues and the periprostatic neurovascular bundles. A clinical non-randomized study conducted in men undergoing radical prostatectomy demonstrated a benefit to recovery of erectile function. Therefore, the hypothesis is that erythropoietin offers nerve protection in men undergoing nerve-sparing radical prostatectomy and results in a reduced degree of erectile dysfunction and also an improved rate of erection recovery following surgery.

Key facts

Study ID

NCT00737893

Run by

Johns Hopkins University

People needed

56

Starts

2017-07-01

Expected to finish

2019-12-31

Last updated by the study team

2021-04-08

Who can join

Age: 40 and older, up to 65. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Patient eligibility consists of men 40 to 65 years of age
• Localized prostate cancer
• clinical stage T2a or lower
• Gleason grade of 3+4 or 3+3
• prostate specific antigen (PSA) < 10
• Scheduled to undergo curative prostatectomy applying bilateral nerve-sparing procedure, with intact pre-surgical erectile function
• International Index of Erectile Function-5 (IIEF-5) score of 22-25.
• The patient has a sexual partner, of at least 6 months.
• The patient's pre-surgical hematocrit is ≤ 48.
• The patient is willing to attempt intercourse at least 5 times per month following recovery from surgery.

You may not qualify if…

• The patient has known penile deformity or a history of Peyronie's disease.
• The patient has planned pre or post operative androgen therapy.
• The patient has planned pre or post operative radiation therapy.
• The patient is on anticoagulation therapy.
• The patient has a history of sickle cell anemia.
• The patient has a history of high or low blood pressure that is not controlled.
• The patient is taking medications called "nitrates"
• The patient has a history of heart problems such as angina, heart failure, irregular heartbeats, or myocardial infarction
• The patient has a history of history of drug or alcohol abuse.
• The patient currently smokes or has a 20 pack/year history of cigarette smoking.
• The patient has a history of acute or chronic depression
• The patient has a history liver problems, or kidney problems.
• The patient has a history of retinitis pigmentosa or severe vision loss, including a condition called NAION, Nonarteritic Anterior Ischemic Optic Neuropathy.
• The patient has a history of spinal trauma or surgery to the brain or spinal cord.
• The patient has contraindications to the use of phosphodiesterase type 5 (PDE 5) inhibitors.
• Patient is currently participating in another clinical investigation that would serve as a contraindication to administering erythropoietin.

Where it is running

• Johns Hopkins Hospital — Baltimore, Maryland, United States

Full record on ClinicalTrials.gov

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